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FDA 510(k)

DILUENT, CELLENT BLOOD

K-Number: K790028 · 1979-02-15

ApplicantSysmex Corp.
Decision Date1979-02-15
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DILUENT, CELLENT BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex Corp.. It received FDA 510(k) clearance on 1979-02-15 under 510(k) number K790028. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILUENT, CELLENT BLOOD?

DILUENT, CELLENT BLOOD is a medical device that received FDA 510(k) clearance on 1979-02-15. The listed applicant is Sysmex Corp.. The 510(k) number is K790028.

When did DILUENT, CELLENT BLOOD receive FDA 510(k) clearance?

DILUENT, CELLENT BLOOD received FDA 510(k) clearance on 1979-02-15, under 510(k) number K790028.

Who is the listed applicant for DILUENT, CELLENT BLOOD?

The FDA 510(k) record lists Sysmex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DILUENT, CELLENT BLOOD?

The FDA product code for DILUENT, CELLENT BLOOD is GIF.

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Other records listing Sysmex Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012372SYSMEX UF-50K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERK981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERK971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETERK964946SYSMEX CA-1000/SYSMEX CA-5000

View all 18 devices →

Related Devices (Code: GIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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